EMA — authorised 1 April 2020
- Marketing authorisation holder: FGK Representative Service GmbH
- Status: approved
🇪🇺 Nexletol in European Union
EMA authorised Nexletol on 1 April 2020
Marketing authorisations
EMA — authorised 1 April 2020
- Application: EMEA/H/C/004958
- Marketing authorisation holder: Daiichi Sankyo Europe GmbH
- Local brand name: Nilemdo
- Indication: Hypercholesterolaemia and mixed dyslipidaemiaNilemdo is indicated in adults with primary hypercholesterolaemia (heterozygous familial and non familial) or mixed dyslipidaemia, as an adjunct to diet:• in combination with a statin or statin with other lipid-lowering therapies in patients unable to reach LDL C goals with the maximum tolerated dose of a statin (see sections 4.2, 4.3, and 4.4) or,• alone or in combination with other lipid-lowering therapies in patients who are statin intolerant, or for whom a statin is contraindicated.Cardiovascular diseaseNilemdo is indicated in adults with establ
- Status: approved
Nexletol in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Metabolic approved in European Union
Frequently asked questions
Is Nexletol approved in European Union?
Yes. EMA authorised it on 1 April 2020; EMA authorised it on 1 April 2020.
Who is the marketing authorisation holder for Nexletol in European Union?
FGK Representative Service GmbH holds the EU marketing authorisation.